Samsung Biologics, Biogen Venture Gets FDA OK for Humira Biosimilar
July 24 2019 - 11:29AM
Dow Jones News
By Colin Kellaher
Samsung Bioepis Co. on Wednesday said the U.S. Food and Drug
Administration approved Hadlima, a biosimilar of AbbVie Inc.'s
(ABBV) blockbuster drug Humira, for several inflammatory
conditions.
Samsung Bioepis, a joint venture between Korea's Samsung
BioLogics Co. (207940.SE) and Biogen Inc. (BIIB) of the U.S., said
the approval covers the treatment of rheumatoid arthritis, juvenile
idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,
adult Crohn's disease, ulcerative colitis and plaque psoriasis.
Biosimilars are near-copies of biologic drugs, such as Humira,
that are made from living cells and are analogous to generic copies
of traditional pill-form medicines.
Humira, the world's biggest-selling drug, had nearly $20 billion
in global sales in 2018, accounting for about 61% of AbbVie's total
revenue.
Sales of Humira biosimilars began in Europe late last year after
a key AbbVie European patent expired, but a group of U.S. patents
built up by AbbVie has prevented a U.S. launch.
Samsung Bioepis said Hadlima will launch in the U.S. after June
30, 2023, under a licensing agreement with AbbVie, adding that
Merck & Co. (MRK) will commercialize the drug in the U.S.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 24, 2019 11:14 ET (15:14 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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